Immunomodulatory Gene Therapy in Patients with Metastatic Breast Cancer: Phase I Trial of Adenoviral vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients with Metastatic Breast Cancer

This is a research study of gene therapy to treat metastatic breast cancer. One of several tumors close to the skin (under the skin, in the chest wall, lymph nodes involved with cancer, or the breast cancer itself) are injected with a genetically altered virus. This altered virus (related to the "common cold" virus) cannot reproduce itself but can produce a substance called interleukin-12 (IL12). IL12 can enhance the ability of the body's immune system to destroy tumor cells. Blood tests and radiology scans will be performed before and after the virus injection to check for side effects and for decrease in the size of the tumors in the body. The virus injection has not been approved by the United States Food and Drug Administration (FDA) for commercial use in the treatment of metastatic breast cancer. Animal studies have shown that a single injection of the altered virus into tumors can destroy tumors in other organs as well and led to some of the treated animals living longer.